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510(k) Data Aggregation
K Number
K132963Device Name
FUSIONSYNC, CHIMAERA FUSIONSYNC
Manufacturer
Date Cleared
2013-12-16
(87 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CHIMAERA GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device FusionSync contains automatic registration algorithms that are intended for the spatial synchronization of different series. The automatic algorithm is not intended for the registration of series from modalities other than: CT, conventional MRI, PET or SPECT. In addition, the product contains a manual mode (non-automatic) that allows the registration via user interaction such that for example automatic registration results can be refined. The intended clinical use is to display different 3D series from the same patient in spatial synchronization as for example, but not limited to, followup examinations. The displayed series can be visualized as MPR views with arbitrary 3D orientation. It is possible to overlay a registered series onto an MPR view. The spatial synchronization and optional overlay, based on the registration result, is intended to help the clinician to obtain a better understanding of the joint information of two registered images. The clinician retains the responsibility for making the diagnosis based on their standard procedures where the separate unregistered images are compared visually. FusionSync complements these clinical standard procedures.
Device Description
FusionSync is a software program that provides a registration engine to align (register) pairs of images from same and different imaging modalities. The platform-independent registration engine is designed as a plug-in component that has the ability to extend the productivity of existing viewers like CAD workstations or PACS. The graphical user interface of FusionSync is designed as a plug-in component for avean workstation OsiriX PRO. It includes functionality to display the original volumetric data and the results of the registration operation. The graphical user interface allows to control the registration engine and fusion visualization.
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